Shire LLC has received a Paragraph IV Notice Letter from Sandoz Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of all strengths of VYVANSE.
Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, announced London-based Logos Technologies as a Medidata Technology Partner.
AMSBIO has announced the launch of the PluriPCR Kit, a new benchmark to revolutionize the definition of stem cell pluripotency. The PluriPCR kit has been designed as a quantitative and reliable assay of five genes strongly specific to pluripotency.
Greiner Bio-One North America, Inc. now offer the Cellmaster Roller Bottle product portfolio, designed to fulfill different requirements for the production of virus vaccines or recombinant proteins used for therapeutic approaches.
TxCell SA announces the approval by AFSSAPS, the French regulatory agency, of its application to extend treatment of patients included in the Crohn’s Disease phase 1/2 study with Ovasave, a type 1 regulatory T cell based immunotherapy.
TikoMed AB announced that TM-400 has been granted orphan drug designation for treatment to mobilize progenitor cells prior to stem cell transplantation by the European Medicines Agency.
Drugmaker Pfizer said that European regulators have approved its highly-anticipated blood thinner Eliquis to prevent blood clots in patients who have had hip or knee replacement surgery.
Drugmaker Merck & Co. said that a European drug agency has endorsed its hepatitis C treatment Victrelis, also known as boceprevir - a key step toward possible approval in the European Union.
The Food and Drug Administration said it approved a new HIV drug from Johnson & Johnson for patients who have not been treated with other medications for the virus.
Pearl Therapeutics Inc. presented efficacy and safety results in the company's Phase 2b study of PT003 (GFF MDI) in patients with moderate-to-very severe COPD at the annual meeting of the American Thoracic Society (ATS).
An independent safety review committee reported study findings on nearly 190,000 females who received at least one dose of Merck’s Gardasil, a quadrivalent human papillomavirus vaccine (qHPV) at two managed care associations between August 2006 and March 2008.
David M. Kendall, MD, currently chief scientific and medical officer of the American Diabetes Association, has been named distinguished medical fellow for Lilly.
SciFluor Life Sciences has secured $5 million in first-round funding from Allied Minds for a technology that enables late-stage fluorination of pharmaceutical drug candidates and other commercial chemicals.
While physicians routinely prescribe statin therapy combined with ezetimibe for some patients with high cholesterol., a study by University of Virginia Health System researchers adds to mounting evidence that ezetimibe may not stop significant artery wall thickening, or atherosclerosis, in some patients.
Penn State University scientists have assembled entire chromosomes from their component parts in a test tube, an achievement that reveals the process a cell uses to package the basic building blocks of an organism's genome.